Adverse event data capture and alert systems and methods

ABSTRACT

Electronic capture of adverse event information includes selective input of adverse event information into a machine in response to prompt provided to the user based on a site visit. Such adverse event information is forwardable to a location over a communication link. The machine produces one or more alerts, if adverse event information has been input, after a prescribed period of time has transpired unless the machine is informed that the same information has already been forwarded to the location. In a preferred embodiment, the customer is a clinician. Optionally, received adverse event information can be parsed to audit whether any of the information, in fact, concerns an adverse event. Systems and software concerning related technological improvements are disclosed.

This patent application claims the benefit of priority under 35 U.S.C.§119(e) of U.S. Provisional Application Ser. No. 60/867,923, filed onNov. 30, 2006, entitled “Adverse Event Data Capture Software, Systems,And Methodologies,” and of U.S. Provisional Application Ser. No.60/863,243, filed Oct. 27, 2006, entitled “Territory Management System,”which are hereby incorporated by reference in their respectiveentireties.

FIELD OF THE INVENTION

The present invention relates to the capture and reporting of adverseevent information by field representatives of manufacturers and serviceproviders, and, more particularly, to a software, systems andmethodologies that assist in the capture and timely reporting of adverseevent information.

BACKGROUND OF THE INVENTION

For several reasons, adverse events associated with medical andnon-medical products need to be identified and reported. In thepharmaceutical sector, for example, safety testing typically goesthrough several phases prior to medicine being made commerciallyavailable, either as a prescribed medication or for over-the-counterconsumer purchase. Indeed, safety studies are required for medical andrelated products such as drugs, biologicals, medical devices andcosmetics in order to receive approval from Federal agencies such as theFood and Drug Administration (“FDA”) to release such products to market.However, vigilance in identifying safety issues continues throughout themarket life of such products. Post-marketing vigilance, however, is lessformal and normally involves voluntary reporting of potential adverseevents by the professionals who become aware of an event. Manufacturersin the medical and pharmaceutical sectors are required to disclose trueadverse events caused by their products to the FDA. However, becausethere can be uncertainty as to whether a given adverse event was causedby a product or not, investigations must be taken to explore the eventwith persons knowledgeable of the circumstances.

In one approach described in U.S. Pat. No. 6,952,695, a system managesthe input of reported adverse event information using a hierarchicallystructured set of predefined terms to guide the user (presumably, aphysician) in the data entry. The system of the '695 patent categorizesand characterizes the reported information and dynamically converts itinto a standardized output that can be stored.

In many sectors including the pharmaceutical sector, fieldrepresentatives have assigned territories and knowledge of theprescribing habits of the doctors and health care professionals in theirterritories and are in an advantageous position to capture and forwardany adverse events to the pharmaceutical manufacturer for investigationand reporting, as appropriate. Tools are needed to assist fieldrepresentatives in capturing any adverse event information that they maybecome of aware of in connection with a site visit to a physician, andto facilitate ensuring that such information is brought to the attentionof the pharmaceutical manufacturer for investigation and reporting, asappropriate, in a timely manner. The present invention addresses thisneed and others.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention, a computer-assistedmethod for electronically capturing adverse event information that isknown is provided which enables such information to be forwarded toanother location by way of a communication link. The method includessteps that call for selectively inputting adverse event information inresponse to prompt. Any such adverse event information is forwarded tothe location over the communication link. The machine into which thisinformation has been input produces one or more alerts, if adverse eventinformation has been input, if a prescribed period of time hastranspired yet the machine has no indication that the adverse eventinformation has been forwarded to the other location.

In further, optional aspects of the invention, received information in acall note can be parsed to audit whether any of the information, infact, concerns an adverse event, and can be further processed by havingthe user confirm the findings of such an audit.

In a further aspect, the invention concerns a computer-readable mediumwhich stores computer-executable instructions for causing a machineprogrammed thereby to the steps of prompting the user to enter adverseevent information before completing a call note entry or beforecommitting such an entry to a database, and forwarding any such input,adverse event information over a communication link. Further, theinstructions cause the machine to produce one or more alerts if adverseevent information has been input, each alert being produced after a timeassociated with receipt of the call note entry, in response torespective prescribed time periods transpiring prior to the forwardingstep being performed.

In still a further aspect of the invention, a system for electronicallycapturing adverse event information known to a prescriber is describedfor forwarding such information to a location. The system comprises afirst machine at the location and connectable to other machines througha communication link and a second machine having a processor and adatabase. The processor is configured to prompt a user to provideadverse event information before completing a call note entry or beforecommitting such an entry to a database, to establish the communicationlink to the first machine at the location, and forward any receivedadverse event information to the first machine over the communicationlink; and to produce one or more alerts if adverse event information hasbeen received, each alert being after a time associated with the receiptof the call note entry and being in response to respective prescribedtime periods transpiring prior to forwarding of the adverse eventinformation.

DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a flow diagram illustrating certain steps in accordance withone embodiment of the invention;

FIG. 2 is a sample call notes entry form suitable for capturing adverseevent information and other information from a representative's visit toa prescriber; and

FIG. 2A is a continuation of the sample call notes entry form of FIG. 2,connected along match line A-A′.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

By way of overview and introduction, a territory management systemprovides representatives with a tool for conducting their activities inan efficient manner, and in particular includes functionality adapted tobetter ensure compliance with regulatory reporting requirementsconcerning adverse events and assists manufacturers in identifying andacting upon such information with warnings, product labeling andrecalls.

The management system is preferably implemented as a software-basedsystem, having components executing on a number of systems including acentral computer and a multiplicity of remote machines, with eachrepresentative having a remote machine for his or her personal use andfor forwarding adverse event information to a location associated withor accessible by the central computer. Without loss of generality, thepresent invention is described in relation to a particularrepresentative using a single remote machine in the course of his or heractivities covering an assigned territory. In the preferred embodimentdescribed below, the representative is bespoke or contracted to apharmaceutical manufacturer, and the representative “covers” a territorythrough visits to physicians and nurses (more generally, “prescribers”)at which the representative is able to discuss and promote the use ofthe manufacturer's products.

A preferred software tool for territory management is described in theaforementioned U.S. Provisional Application Ser. No. 60/863,243. Thissoftware provides through a Web-browser interface a number of tools thatassist the representative in planning, recording, and trackingactivities with clinicians (which generally include prescribers, medicalassistants, pharmacists) or customers, as the case may be. This softwarealso includes features that assist a representative with complianceissues concerning certain state or federal requirements (e.g., limitsand restrictions concerning gifts to health care professionals), and canassist in reducing discrepancies in sample inventories as between storedand on-hand inventories. Various features of this software are describedin other patent applications, now co-pending.

Referring now to FIG. 1, a flow diagram illustrates functionalitysuitable for capturing adverse event (AE) information that arepresentative may learn about in the course of covering his or herterritory. Because the representative makes a point of visitingprescribers he or she may be the first person to learn of an eventconcerning a patient's use of a particular pharmaceutical. Likewise, inother fields, the representative can learn of a strain, performancechange, part failure, and the like concerning a product, machine,system, process, or software concerning the subject matter that therepresentative represents, and for ease of discussion all suchdevelopments are referred to as “adverse events.”

The process illustrated in FIG. 1 concerns an appointment of therepresentative, which can be a scheduled appointment or a “drop-in”visit. In the area of pharmaceutical representation, it is common for arepresentative to drop-in on a prescriber within the representative'sassigned territory with the hope that the prescriber will be able tospeak with the representative for a few minutes. The nature of suchvisits can vary from informal to formal, but one objective of therepresentative is to promote a prescriber's familiarity andunderstanding of pharmaceuticals that the representative wishes theprescriber to prescribe to patients. In other fields, the representativesimilarly has an objective of promoting purchase and use of his or herrepresented products and services through educational and promotionalefforts.

Thus, at block 102, the representative makes a site visit to aparticular prescriber's office. The representative typically makes anumber of visits during the course of a day, whether scheduled ordrop-in, and these visits can be coordinated through a calendar functionprovided by the same programmed system that handles a representative'sreporting of newly disclosed adverse event information. The schedulingand calendar functions form no part of the present invention.

In the event that the prescriber is not available, for a conference withthe representative, as conceptually indicated by the test at block 104,the representative goes to a next appointment by traveling to anothersite within his or her territory, preferably with guidance from acalendared set of appointments that fill the day. If, however, aconference is held with a prescriber at a particular site visit, thenthe representative is supposed to capture a summary of who was met, whatproducts (services) were discussed, whether samples were provided (anddetails concerning same), and propose a next meeting and follow-updiscussion points.

Representatives generally seek to satisfy any concerns expressed by theclinicians in their territory, and so follow-up points can be capturedin the territory management software so that the representative canbetter address those concerns with their clinicians. However,representatives also have an obligation to the company they represent todocument any reported adverse events as those events might requirefurther investigation or follow-up, and for at least some adverse eventshave a legal obligation to report such events within a limited window oftime after learning of the event, such as within 48 hours.

Use of the territory management system commences then at block 106 atwhich the representative initiates the entry of visitation notes, knownas making a “call completion” because he or she has completed a salescall to the clinician/customer and has meeting notes to record. The usercan initiate this data entry process in a variety of ways. For example,from a calendar feature of the management system an icon such as atelephone icon can be selected to bring up a call notes entry form.Alternatively, the calendar feature of the management system can includeentries showing the time, location, or both of the visits for that daywhich the representative can select to bring up the call-notes entryform. Yet another alternative is that the representative can call up aprescriber summary page which can include a link (or an icon asmentioned above) to enter call notes that are to be associated with thatprescriber visit.

Preferably, prior to enabling entry of the call notes, the softwareprompts the representative (user) through the interface at block 108 asto whether he or she was informed of any adverse event informationduring the course of the site visit, including, by way of examples, anadverse event, a report of concern (“ROC”), a product complaint, orother information that satisfies a standard operating procedure forreporting such events. The field-capture of such information is of vitalimportance to the pharmaceutical sector, and can be important in othersectors as well, and so in a preferred implementation, an alert such asa dialog box is presented to the user to confirm whether any suchinformation was discussed during the conference with the prescriber. Thealert can require an affirmative response by the user to expose or causethe call-notes entry form to be presented. Thus, for example, the alertcan be a conventional dialog box with a text string requesting whethersuch information was discussed and two buttons, one. “yes” and one “no”.After receiving the user's response, the call-notes entry form can bepresented with a selection list populated with the value selected by theuser (and optionally changeable during the course of call-notes dataentry). Alternatively, the adverse information prompt can comprisefields within the call notes entry form without the use of, a separatealert or dialog box. Regardless of the form for the prompt, it ispreferably provided prior to the call notes entry form being completed,for example, before it is committed (written to) to the local database.

At block 110, a test is made to determine the value input by therepresentative in response to the prompt from block 108. Of course, ifthe prompt was not provided at this stage, no test is required. The usercan selectively input adverse event information, depending on whether heor she has such information to be captured. In the event that the userindicates that an AE was discussed (block 110: “YES”), then the processflow branches to block 150, discussed below, with the softwareresponding to the user input with steps that affirmatively capture andforward a minimum set of required information to a central machine. Ifthe user indicates that there is no adverse event information to report,then the user can proceed to input call notes through the call-notesentry form, at block 112. An exemplary call-notes entry form 200 isshown in FIG. 2.

Among a variety of fields that can be provided, typically there arecertain data fields which are set for required data entry in order forthe form completion to be validated. Region 210 includes a variety offields for call note capture, including certain required, data-fieldsindicated with highlighted marks next to them (e.g., Location, Startdate time, etc.). Several of the data fields are preferably populatedwith information directly from the representative's calendar. Thus, ifthe call notes are in furtherance to a calendared visit, the particularprescriber, his or her address, start time, end times, and the call typecan all be known from the calendar entry. Among the data-fieldsprovided, the representative can indicate whether a sample was droppedoff (as well as other details as described in co-pending U.S.Provisional Application Ser. No. 60/867,903, filed on Nov. 30, 2006,entitled “Inventory Control over Pharmaceutical Sample Distributions,Software, Systems and Methodologies”), input a next appointment whichentry can populate the representative's calendar. In addition, there arepreferably selection lists that permit ready identification of whichproducts were presented to the prescriber, and free-text fields in whichthe representative identifies the discussion topics and any objectivesfor follow-up at a next visit. The topics text box 230 and thenext-objective text box 240 are two free text fields which can hold, forexample, up to 1000 characters. Briefly, region 220 includes fields thatare specific to the capture of adverse event information and isdiscussed below.

Optionally, the call notes entry form can inform the representative ofthe year-to-date spending on that health care professional. This canassist the representative in staying in compliance with state limits ongifts to individual health care professionals, as described inco-pending application Ser. No. 60/867,906, filed on Nov. 30, 2006,entitled “Pharmaceutical Representative Expense Management Software,Systems, and Methodologies,” and is particularly beneficial when morethan one representative from the same manufacturer has paid a call tothat prescriber, directly or indirectly by visiting the same hospital ormedical group and having apportioned expenses to that same prescriber.

Referring again to FIG. 1, when the representative seeks to apply thedata in the call entry form to the local database on the machine he isusing (e.g., a laptop computer or personal digital assistant),validation rules can execute to monitor and flag any entries for theirrespective levels of completion, format, spelling and even content, tobetter ensure that good data is being captured. Thus, for the free-textfields, a minimum of five characters might have to be entered to resultin form validation. Among the validation rules, at block 114, thecontent of the free text fields can be compared against a dictionary orthesaurus of standard terms that might be probative of an AE in-fact.For example, the representative might have documented in the topicsfield 230 a discussion of “pain” or “ache” which the dictionary mightassociate with a likelihood of an AE in-fact. In the event that atrigger term is found within the free-text fields, as determined atblock 116, then the representative can be asked to confirm that the termis not, in fact, associated with an adverse event (in this flow branch,the representative indicated AE? NO at block 110). If the representativeconfirms that the term in the free text field that triggered this auditinquiry was not an adverse event, process flow proceeds to block 120 atwhich time the completed call notes are uploaded to a central database.On the other hand, the representative might wish to revise his wordchoices as a result of this automated audit inquiry, in which caseprocess flow returns to block 112 so that the call notes can be revised.Still another possibility is that the representative reconsiders hisprior indication of no AE and in that case the process flow proceeds toblock 150.

If there are no adverse events to report, then the call notes, onceuploaded to the central database can be downloaded to a manager'smachine, as indicated at block 122. For example, to the machine of adistrict manager whose responsibility is to supervise and review thework of one or more representatives in one or more territories. Once thecall notes have been downloaded to the manager's machine, the managercan review the call notes as well as the productivity of therepresentative (block 124) and can provide feedback (block 126), asappropriate. The process of FIG. 2 generally ends at that point withrespect to a particular call note; however, the representative may makeany number of site visits and enter any number of call notes for eachsuch visit prior to the upload at block 120, and the time frame fordownload, review and feedback by a manager, if any, can be entirelydifferent than the time frame of the events leading to those finalsteps.

In the event that the representative's machine includes a wirelessnetwork capabilities (e.g., a broadband card that can connect themachine through a “hot spot”), the upload at block 120 can occurwhenever the system detects that it has secure network connectivity, andthis process can be performed as a background thread while the userperforms other tasks on the machine running the territory managementsoftware.

The upload to the central database requires a communication link betweenthe central computer and the remote machine of the representative. Theupload is preferably conducted in accordance with co-pending U.S.Provisional Application Ser. No. 60/867,943, filed on Nov. 30, 2006,entitled “Data Cache Techniques In Support Of Synchronization ofDatabases In A Distributed Environment,” which is hereby incorporated byreference in its entirety. During the same communication session, thecentral machine can download information to the representative'smachine, but such downloads are not pertinent to the present invention.Downloads can be to revise the scope of the representative's territory,to provide prescription-writing information on the prescribers in therepresentative's territory, to add new prescribers, and to change theuser's role (e.g., from representative to district manager). Suchdownloads are preferably conducted in accordance with co-pending U.S.Provisional Application Ser. No. 60/867,945, filed on Nov. 30, 2006,entitled “Software, Systems and Methodologies For Realignment of RemoteDatabases By A Central Database In Support of Field RepresentativeTerritory Assignments,” which is hereby incorporated by reference in itsentirety.

Referring now to block 150, in the event that the representative hasindicated that he has AE information to input, the time of the visit iscaptured and used to initialize a local timer on the representative'smachine. The time of this event can be taken from one of the fields ofthe call notes entry form, such as the start date/time or the enddate/time fields. Alternatively, the machine can make a call to itssystem clock and use that time as the basis for the local timer. Thepurpose of the local tinier is to provide an alert to the representativein the event that a prescribed period of time has elapsed yet the systemhas not been informed that the AE information has been communicated. Asnoted above, it is important that such information be promptlycommunicated to the manufacturer so that there is sufficient time toinvestigate the circumstances and determine an action, which couldinclude informing a third-party pharmacovigilance community, the Foodand Drug Administration, or foreign agencies with similar purposes.

At block 152, the AE information is captured in the region 220 of thecall notes entry form, shown in FIG. 2A. This region includes fieldsthat can be pre-populated with information if available from the localdatabase used by the software on the representative's machine. Thus, forexample, the telephone and fax numbers and email address of theprescriber who was visited can be pre-populated, if that information isalready known. The minimum information to be provided in call notesentry form 200 is the sex (male or female) of the patient, the productthat was taken which is attributed to being associated with the AE, anda free-text summary field (e.g., up to 1000 characters) to describe thesymptoms and circumstances of the event. Because AE information ispatient specific, it is preferable to capture a sufficient amount ofinformation to ensure not only that a suitable assessment can be maderegarding the reported event, but also to better ensure that the recordcan be identified as a duplicate in the event that the event has beenseparately reported. In this regard, the patient's initials, age, anddate of birth can be captured as well if that information is provided.

Independent of this data entry, the representative can, and isencouraged to, call in the AE information, which can be indicated in asuitable check-box provided within the region 220.

The user completes AE information entry with an “apply” button to applythe newly entered information to the local database. Likewise, the userinputs call notes, as described above in connection with block 112.

At block 156, a scan of the content of the free text summary field ispreferably performed for comparison against a reference such as adictionary of terms (e.g., the same dictionary as used at block 114 or adifferent dictionary) that might present ambiguity or otherwise beflagged as raising questions upon a later review. For example, the useof the term “pain” or “ache” without the use of a noun identifying theplace of pain or ache could trigger, at block 158 that therepresentative's word choice is not ideal. Alternatively or in addition,the comparison at blocks 113 and 156 can be to a rule base, such as onethat parses the text box for ambiguities or informalities due to grammaror one that parses the text box for particular words or for identifyingcertain frequently used terms by that representative. In the event ofsuch a trigger, the user can confirm his or her word choice at block160, by either indicating a desire to revise the text entries, inresponse to which the software loops back to blocks 152 and/or 154, orby indicating that the entries are acceptable. If the entries entered inthe call notes and the adverse event free-text summary field are deemedto be acceptable to the user, or if no trigger terms were identified,process flow proceeds to block 162.

After the entry of data and commitment to the local database on theuser's machine, a test is made at block 162 whether the representative'smachine can establish a communication channel to the central database.This step precedes the upload at block 120, and, as noted above, istypically a background process but can be attempted in response to auser request, through the software's user-interface, to establish such aconnection. The test as to whether there has been a connection to thecentral database has particular pertinence, however, with regard to thehandling of the AE information. In particular, if no link can beestablished within a prescribed alert time, as tested at block 180, analert is preferably provided to the representative at block 182 that theAE information must be uploaded as soon as possible, or otherwiserelayed to the manufacturer. Thus, for example, alerts can be programmedto display to the user two hours after the site visit, again at fourhours after the site visit, and each hour after that. Such programmingcauses the representative's machine to issue alerts in response to theexpiration or transpiration of the prescribed alert times. Also, thealert to relay the AE information can block other functionality of therepresentative's machine (or at least of the territory managementsoftware) until the alert condition has been satisfied. One possibilityis that the representative may indicate at block 184 that he or she has“called in” the data (see the filled-in check box in region 220), whichmay qualify as a basis for removing the alert, or optionally forreducing the frequency of requesting that an upload communicationsession be established. In that case, the AE information has alreadybeen forwarded to the designated location independently of the use ofthe representative's machine, yet follow-up notifications asking therepresentative to confirm that the information was called in can stillbe provided. However, if the AE information has not been “called-in,”and no link has been established, the alerts will preferably continue.On the other hand, if the link is established (or at some time after theinformation has been called in), the completed call note entry forms andother information are uploaded onto the central database, at block120,and that information is available for manager handling at blocks122, 124 and 126, as previously described.

In addition, at block 164, after uploading to the central database, themanufacturer or an agent thereof implements a standard operatingprocedure by which the AE information is reviewed. That review isunderstood by those of skill in the art, but generally includes one ormore of the following actions: an assessment of the reported data itselfand against other reports and information that are available; a call tothe representative for more details on the call to the prescriber; acall to the prescriber for further information on how the eventtranspired and on the subject patient; a notification to a third-partysuch as a pharmacovigilance community, the Food and Drug Administrationor a foreign agency with a similar role or purpose.

In the foregoing description, certain flow diagrams have been shown andprocesses described in relation to those flow diagrams which provide areference for discussion purposes. In an actual implementation of themethods of the present invention, the steps can comprise event-drivenroutines that can run in parallel and can be launched and executed otherthan as shown by the simple depiction in the flow diagrams. Accordingly,it is the performance of the steps recited in the claims appended belowwhich is pertinent, and not the order of operation of the stepsthemselves.

1-11. (canceled)
 12. A computer-assisted method for electronicallycapturing adverse event information in order for said information to beforwardable to a location by way of a communication link, comprising thesteps of: providing a user with at least one adverse event informationprompt using instructions executable in a processor of the machine;receiving as an input to the machine, adverse event information from theuser; testing whether the machine can establish a communication link tothe location; in the event that the communication link can beestablished, forwarding the input adverse event information to thelocation over the communication link; and until such time that thecommunication link can be established, and prior to the forwarding stepbeing performed, producing one or more alerts at the machine usingprogramming in the processor that the adverse event information muststill be forwarded to the location.
 13. The method of claim 12, furthercomprising entering into the machine a note concerning a visit by theuser, and identifying to the machine that the forwarding step has beenperformed by associating a called-in status with the note.
 14. Themethod of claim 12, wherein the performance of the forwarding step isindicated by a filled-in check-box among the input adverse eventinformation.
 15. The method of claim 12, further comprising enteringinto the machine a note concerning a visit by the user, and comparingany input adverse event information, the entered note, or both, againsta reference and selectively prompting the user to confirm saidinformation.
 16. The method of claim 15, wherein the reference used inthe comparing step is a dictionary or thesaurus.
 17. The method of claim15, wherein the reference used in the comparing step is a rule base. 18.The method of claim 12, further comprising entering into the machine anote concerning a visit by the user, wherein the step of providing theat least one adverse information prompt is prior to the note beingcompleted.
 19. The method of claim 12, wherein the step of providing theat least one adverse information prompt includes the step of presentinga dialog box on a screen of the machine, and wherein at least one of theprompts requires a response to be input to the machine in order to closethe dialog box.
 20. The method of claim 12, including the additionalstep of comparing any input adverse event information against areference and selectively prompting the user to confirm saidinformation.
 21. The method of claim 20, wherein the reference used inthe comparing step is a dictionary or thesaurus.
 22. The method of claim20, wherein the reference used in the comparing step is a rule base. 23.The method of claim 12, further comprising entering into the machine anote concerning a visit by the user, wherein the forwarding step furtherincludes forwarding the note to the location over the communicationlink.
 24. A non-transitory computer-readable medium storingcomputer-executable instructions for causing a machine programmedthereby to: provide a user with at least one adverse event informationprompt using instructions executable in a processor of the machine;receive as an input to the machine, adverse event information from theuser; test whether the machine can establish a communication link to acentral machine; in the event that the communication link can beestablished, forward the input adverse event information to the centralmachine over the communication link; and until such time that thecommunication link can be established, and prior to any forwarding,produce one or more alerts at the machine that the adverse eventinformation must still be forwarded to the central machine.
 25. Thenon-transitory computer-readable medium of claim 24, further storingcomputer-executable instructions for causing the machine programmedthereby to initialize a timer within the machine in response to themachine receiving the input adverse event information, the timer havinga prescribed time period.
 26. The non-transitory computer-readablemedium of claim 25, wherein the prescribed time period is obtained froma system clock of the machine.
 27. The non-transitory computer-readablemedium of claim 25, further storing computer-executable instructions forcausing the machine programmed thereby to enter into the machine a noteconcerning a visit by the user, wherein the prescribed time period iscommences with the entry of the note into the machine.
 28. A system forelectronically capturing adverse event information known to a prescriberfor forwarding to a location, comprising: a first machine at thelocation and connectable to other machines through a communication link;a second machine having a processor, the processor being configured byinstructions executable in the processor to: provide a user with atleast one adverse event information prompt using instructions executablein a processor of the machine; receive as an input to the machine,adverse event information from the user; test whether the machine canestablish a communication link to the first machine at the location; inthe event that the communication link can be established, forward theinput adverse event information to the location over the communicationlink; and until such time that the communication link can beestablished, and prior to any forwarding, produce one or more alerts atthe machine that the adverse event information must still be forwardedto the location.
 29. The system of claim 28, wherein the processor ofthe second machine is further configured by instructions executabletherein to initialize a timer within the machine in response to themachine receiving the input adverse event information, the timer havinga prescribed time period.
 30. The system of claim 29, wherein theprescribed time period is obtained from a system clock of the machine.31. The system of claim 29, wherein the processor of the second machineis further configured by instructions executable therein to enter intothe machine a note concerning a visit by the user, wherein theprescribed time period is commences with the entry of the note into themachine.